Sodium Chloride Injection USP 0.9%
范仲淹的简介
PRESCRIBING INFORMATION
Rx only
Mallinckrodt Inc.
For Intravascular U Only
DESCRIPTION周记800字高中
Sodium Chloride Injection USP 0.9% is a formulation of sodium chloride in Water for Intravascular Injection. No prervative, antimicrobial agent or buffer is added. Sodium Chloride Injection USP 0.9% is provided as a sterile, nonpyrogenic, clear, colorless, odorless solution.
Each mL of Sodium Chloride Injection USP 0.9% contains 9 mg of sodium chloride. The pH is 4.5 to 7.0. The osmolarity is 308 mOsm/L (calc.). Sodium Chloride Injection USP 0.9% is designated chemically as sodium chloride and its molecular formula is NaCl. Its molecular weight is 58.44.
Sodium Chloride Injection USP 0.9% is provided in a 50 mL syringe with a 50 mL fill and a 125 mL syringe with a 125 mL fill. The syringes are for single patient u and are disposable and not meant for reu.
CLINICAL PHARMACOLOGY
Sodium Chloride Injection USP 0.9% has approximately the same osmotic pressure as plasma.
INDICATIONS AND USAGE
大鱼海棠台词50 mL Syringe
Sodium Chloride Injection USP 0.9% is indicated for u in flushing compatible contrast agents through Mallinckrodt intravenous administration ts into indwelling intravascular access devices when delivered manually or by the following Mallinckrodt power injectors: Optistar™ LE and Optistar™ Elite™.
125 mL Syringe
Sodium Chloride Injection USP 0.9% is indicated for u in flushing compatible contrast agents throu
gh Mallinckrodt intravenous administration ts into indwelling intravascular access devices only when delivered by the following Mallinckrodt power injectors: Angiomat™, Illumena™, CT9000™, CT9000™ ADV, Optistat™, Optivantage™ and Optistar Elite.
CONTRAINDICATIONS
盐的用途
None known.海豚介绍
WARNINGS AND PRECAUTIONS
Air Embolism
REMOVE ALL AIR FROM THE SYRINGE AND ASSOCIATED TUBING PRIOR TO INJECTION TO AVOID AIR EMBOLUS WITH THE ASSOCIATED RISK OF STROKE, ORGAN ISCHEMIA AND/OR INFARCTION, AND DEATH.
Infectious Complications
U aptic technique. Inspect the syringe for signs of break in sterility. Do not u if the syringe shows signs of damage, leakage or a loo fitting tip cover (e DOSAGE AND ADMINISTRATION,
Asmbly and Inspection). Do not u if the solution is cloudy or discolored or contains particulate matter. U of a damaged syringe or failure to maintain aptic technique may result in infection, psis and death.
Fluid Overload
Sodium Chloride Injection USP 0.9% should be ud with great care, if at all, in patients with congestive heart failure, vere renal insufficiency, and in clinical states with edema, sodium retention, or hypernatremia.
Each patient’s age, body weight, fluid status, concomitant medical conditions and planned radiological procedure should be taken into account to determine if u of Sodium Chloride Injection USP 0.9% is appropriate for them.
Extravasation
Mechanical compression of neurovascular structures may result from extravasation of the normal saline. Extravasation of contrast agent may result in tissue injury by osmolar and direct cytotoxicity (e package inrts of specific contrast agents). Intravascular catheter patency must be established prior to the administration of Sodium Chloride Injection USP 0.9%.
Do not reu. For single patient u only. Do not u if the syringe, piston, or tip cap are damaged in any way. Do not u if the tip cap is loo or if there are signs of leakage.
Pregnancy Category C
Animal reproductive studies have not been conducted with Sodium Chloride Injection USP 0.9%. It is also not known whether Sodium Chloride Injection USP 0.9% can cau fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection USP 0.9% should be given to a pregnant woman only if clearly needed.
Pediatric U
Safety and effectiveness of Sodium Chloride Injection USP 0.9% administered by power injection in pediatric patients have not been established. Administration of Sodium Chloride Injection USP 0.9% to pediatric patients by power injection is not recommended. Manual injection of Sodium Chloride Injection USP 0.9% to pediatric patients should take into account the patient’s weight, fluid status, and concomitant medical conditions to determine if u of Sodium Chloride Injection USP 0.9% is appropriate.
The safety of manual injection of Sodium Chloride Injection USP 0.9% in pediatric patients is supported by reported clinical experience with intravenous infusion and flush of sodium chloride injection in pediatric patients.
To minimize the risk of fluid overload, the smallest do of Sodium Chloride Injection USP 0.9% necessary for manually flushing contrast agent through the vascular access line should be ud. Geriatric U
No clinical studies of Sodium Chloride Injection USP 0.9% were conducted. Other reported clinical experience with sodium chloride injection has not identified differences in respons between the elderly and younger patients. In general, do lection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decread hepatic, renal, or cardiac function, and of concomitant dia or other drug therapy.
ADVERSE REACTIONS
There may be reactions due to solution or technique of administration which include air embolization with stroke, chest pain, and dyspnea, arrhythmia, hypotension, myocardial infarction, psis, febrile respon, local tenderness, infection at the site of injection, venous thrombosis or phlebitis extendin
g from injection site, extravasation, fluid overload, and hypervolemia.
OVERDOSAGE
U of Sodium Chloride Injection USP 0.9% may po a threat of overdo marked by electrolyte disturbance and/or fluid overload, particularly in pediatric patients and patients with compromid renal or cardiac function. In the event this should occur, discontinue the infusion, reevaluate the patient and institute appropriate corrective action.
DOSAGE AND ADMINISTRATION
The 50 mL syringe and the 125 mL syringe are intended for Single Patient U.
The volume of the saline flush should be determined for each patient individually bad, in part, on the imaging procedure, the location of the vascular access device, the length of tubing between the Mallinckrodt contrast agent power injector and the vascular access device and the recommendations made on the package inrt for the contrast agent. Typical Sodium Chloride Injection USP 0.9% flush volumes following contrast agent administration in adults are 10 to 25 mL per injection at rates not to exceed 10 mL/c.
U of some Mallinckrodt contrast agent power injectors allows for additional infusion of Sodium Chloride Injection USP 0.9% to maintain the patency of vascular access. Typical infusion rates ud for this purpo are in the range of 0.5 to 1 mL per minute.
Infusion rates and flush volumes should be individualized for each patient bad on their body weight, fluid status and concomitant medical conditions.
栋的成语Consult the Mallinckrodt contrast agent power injector manual for proper u.
Drug Handling
EXPEL AIR BEFORE USE.
Do not u if packaging is damaged, wet or not intact. Do not u if the syringe or its cap is damaged or displaced, or if any leakage is evident. Do not u if solution is hazy, cloudy, discolored or contains particulate matter.
U aptic technique.
Residual air in both the syringe and tubing should be expelled prior to connection with the patient’s vascular access.
Instructions for asmbly and inspection of the Sodium Chloride Injection USP 0.9% syringes prior to u are printed on this sheet.心烦图片
HOW SUPPLIED
十年英文Sodium Chloride Injection USP 0.9% is a clear, colorless, odorless solution containing 0.9 mg/mL of sodium chloride. Sodium Chloride Injection USP 0.9% is supplied in 50 and 125 mL syringes containing 50 and 125 mL of solution respectively. Each syringe is aled with rubber closures and the contents are sterile. The 125 mL syringe is supplied with a luer locknut adapter which is cleared for manufacture and distribution as a device under 510K 862653. The syringes are contained in shipping cartons with the following configurations:
50 mL in plastic syringes in cartons of 10 syringes
(NDC Code 0019-1188-75)
125 mL in plastic syringes in cartons of 20 syringes
(NDC Code 0019-1188-81)
125 mL in plastic RFID-Tagged Syringes* in cartons of 20 syringes
(NDC Code 0019-1188-27)
*Radio Frequency Identification (RFID) Technology
This information is for Ultraject™ syringes containing Sodium Chloride Injection USP 0.9% that has been labeled with a Radio Frequency Identification (RFID) tag. When ud with an RFID-enabled Optivantage injector, this tag allows for the exchange of product information such as lot number, expiration, concentration, and identification of the syringe as being unud prior to u and ud after product administration. Patient information is not utilized in any form with this RFID technology. Sodium Chloride Injection USP 0.9% product quality is not impacted with the u of this RFID tag. Sodium Chloride Injection USP 0.9% RFID syringes require no special handling and should be stored at the conditions listed for the drug product.
RFID-Tagged Syringe Directions for U
For the RFID Technology to function, the syringe must be ud with an Optivantage Injector with RFID technology. Function of the RFID technology is not dependent on syringe orientation as it is placed in the injector. Instructions for u of injector are provided on the injector interface screens and operator’s manual.
If the RFID tag is damaged or otherwi non-functional, the injector will notify the ur. Should this occur the Sodium Chloride Injection USP 0.9% syringe with the non-functional RFID tag may still be ud but no data will be transferred to the injector. Regarding interference with medical devices, the RFID tag and injector system meet the IEC 60601-12 requirements for emission and immunity standards for medical devices. Follow all manufacturers’ guidelines and do not operate any part of the Optivantage Injector System and RFID-tagged syringes within 6 inches (15 cm) of a pacemaker and/or defibrillator. Storage: Store Sodium Chloride Injection USP 0.9% syringes and RFID-tagged syringes at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [e USP Controlled Room Temperature]. PROTECT FROM FREEZING Optistat, Optivantage, Optistar, Optistar Elite, Angiomat, Illumena, and CT9000 are trademarks of Mallinckrodt Inc. or an affiliate. Manufactured and Distributed by:
Mallinckrodt Inc. tyco Healthcare Hazelwood, MO 63042
MKR 11880408
Revid 04/08 Printed in U.S.A.
50 mL Syringe:
Asmbly and Inspection
NOTE: Exterior of syringe is not sterile. Contents of syringe and area under tip cap and piston ribs are sterile and should be
Remove syringe from carton and inspect
the area around the tip cap and outside of
piston for signs of leakage. Do not u if
leakage is obrved.
treated accordingly. After screwing the push rod into the syringe piston, it is important to turn the
push rod and additional 1/2 turn so that
the piston rotates freely.
